Senior Clinical Research Associate – FSP
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Job Description
Senior Clinical Research Associate monitoring clinical trials for Thermo Fisher Scientific’s global life-science solutions. Ensuring protocol compliance, data quality, site management and audit readiness.
Responsibilities:
- Perform and coordinate all aspects of clinical monitoring and site management
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation and sponsor/monitoring-environment procedures and guidelines
- Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
- Ensure audit readiness and develop relationships with investigational sites
- Monitor investigator sites using a risk-based monitoring approach
- Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions
- Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters using approved business writing standards
- Escalate deficiencies and issues to clinical management and follow through to resolution
- Maintain contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Investigate and follow up on findings
- Provide trial status tracking and progress updates to the Clinical Team Manager
- Update study systems, including CTMS, and perform required CTMS report quality-control checks
- Participate in investigator meetings
- Identify potential investigators with the client company
- Initiate clinical trial sites and make compliance recommendations
- Ensure trial closeout and retrieval of trial materials
- Ensure essential documents are complete and in place; conduct on-site file reviews
- Contribute to project publications, tools and process-improvement initiatives
- Perform additional study tasks assigned by the CTM
- Facilitate communication between investigative sites, client company and PPD project team
- Respond to company, client and regulatory requirements, audits and inspections
- Complete expense reports and timesheets
- Frequent travel to site locations, generally 60–80% or more
Requirements:
- Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification
- Valid driver's license where applicable
- 3+ years as a clinical research monitor, or comparable experience providing the required knowledge, skills, and abilities
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and medical terminology
- Understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
- Critical thinking, root cause analysis and problem-solving skills
- Ability to manage Risk Based Monitoring concepts and processes
- Effective oral and written communication skills with medical personnel
- Customer focus, listening skills, attention to detail and ability to perceive underlying customer issues
- Effective interpersonal skills
- Strong attention to detail
- Ability to comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information
Benefits:
- Comprehensive health and wellbeing benefits
- Wellness programs
- Employee Assistance Program providing confidential support for personal and work-related issues
- Flexible arrangements
- Generous leave policies
- Option to purchase additional leave
- Paid birthday leave
- Company paid parental leave
- Paid volunteer time
- Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning
- Workshops and mentorship programs
- Employer recognized by WGEA as an Employer of Choice for Gender Equality
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